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CTRI Number  CTRI/2025/06/088664 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to find out how common Vitamin D deficiency is among adults visiting a hospital in Kerala 
Scientific Title of Study   A clinico- epidemiologic cross-sectional study of Vitamin D Deficiency among adulthood patients visiting the laboratory of a tertiary Care Hospital in Kerala 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kasthuri Nair A  
Designation  Director  
Affiliation  Pankajakasthuri Ayurveda Medical college and PG centre  
Address  Room No:1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  8113851665  
Fax    
Email  dr.kasthurinair@pkhil.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Pratap 
Designation  Professor  
Affiliation  Pankajakasthuri Ayurveda Medical college and PG centre  
Address  Room No:1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  9567256333  
Fax    
Email  dr.arunpratap@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Pratap 
Designation  Professor  
Affiliation  Pankajakasthuri Ayurveda Medical college and PG centre  
Address  Room No:1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  9567256333  
Fax    
Email  dr.arunpratap@gmail.com  
 
Source of Monetary or Material Support  
Neyyar Medicity, Kattakada, Trivandrum, Kerala, Pin -695572 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [Student funded project] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kasthuri Nair A  Neyyar Medicity  Room NO 1 Department of General Medicine
Thiruvananthapuram
KERALA 
8113851665

dr.kasthurinair@pkhil.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Adults aged 18 to 50 years
2. Both male and female patients visiting the laboratory for vitamin D testing
3. Willing to participate and provide informed consent
4. Capable of understanding and answering the questionnaire
 
 
ExclusionCriteria 
Details  1. Patients with known chronic diseases affecting vitamin D metabolism (e.g., chronic kidney disease, liver disorders, parathyroid dysfunction)
2. Pregnant or lactating women
3. Patients unwilling to participate or unable to provide informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Vitamin D deficiency among adult patients visiting the laboratory  The assessment will be Prevalence of Vitamin D deficiency will be evaluated at Day 1, i.e., on the day of the participants visit to the laboratory 
 
Secondary Outcome  
Outcome  TimePoints 
• Outcome 1: Association of Vitamin D deficiency with lifestyle, dietary habits, sunlight exposure, physical activity, & BMI
• Outcome 2: Knowledge & awareness level regarding vitamin D among the study population
 
The assessment will be conducted at Day 1, i.e., on the day of the participants visit to the laboratory using a structured, interviewer-administered questionnaire. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Vitamin D deficiency is a globally prevalent public health problem, with substantial implications for bone health and metabolic functions. Despite abundant sunshine, India, including the southern state of Kerala, reports high prevalence of vitamin D deficiency due to factors like sedentary lifestyle, indoor confinement, dietary habits, and cultural practices. This study aims to assess the prevalence of vitamin D deficiency among adults (aged 18–50 years) attending the laboratory of a tertiary care hospital in Kerala, specifically Neyyar Medicity.

This cross-sectional study will involve 60 adult participants who undergo serum 25-hydroxyvitamin D testing. Data collection will be conducted through a structured and validated questionnaire that captures socio-demographic data, sun exposure, dietary patterns, lifestyle factors, and awareness about vitamin D. The primary objective is to estimate the proportion of individuals with deficient vitamin D levels, while secondary objectives include identifying contributing risk factors and gauging participant knowledge about deficiency symptoms and consequences.

Findings from this study are expected to guide awareness campaigns and preventive strategies in the community and contribute to developing public health recommendations to tackle this silent epidemic. Ethical approval has been obtained from the Institutional Ethics Committee of Pankajakasthuri Ayurveda Medical College and PG Centre, Trivandrum.

 
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